True-Lock 9471S

GUDID 05708932987967

Plug

Coloplast A/S

Inflatable penile prosthesis

• Primary Device ID: 05708932987967
• NIH Device Record Key: e723538d-74c7-41b1-a20c-5a84c00c2f39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True-Lock
• Version Model Number: 9471S
• Catalog Number: 9471S
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8002583476
• Email: urology@coloplast.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932987967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000006

FDA Product Code

• FHW: Device, Impotence, Mechanical/Hydraulic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-07-21

Devices Manufactured by Coloplast A/S

• 05708932769334 - Biatain Fiber: 2024-12-20
• 05708932769365 - Biatain Fiber: 2024-12-20
• 05708932769396 - Biatain Fiber: 2024-12-20
• 05708932769426 - Biatain Fiber: 2024-12-20
• 05708932764490 - Biatain Fiber Ag: 2024-12-02
• 05708932764551 - Biatain Fiber Ag: 2024-12-02
• 05708932764568 - Biatain Fiber Ag: 2024-12-02
• 05708932764520 - Biatain Fiber Ag: 2024-12-02